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临床试验/NCT02496247
NCT02496247已完成不适用

Effectiveness of Canned Herring for Prevention of Childhood Malnutrition During the Early Rainy Season in Rural Guinea-Bissau

Global Food & Nutrition Inc.0 个研究点目标入组 1,200 人开始时间: 2015年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,200
主要终点
Change from Baseline in weight-for-age Z-score

研究概览

简要总结

This study will test the effectiveness of a weekly village distribution of canned herring for prevention of malnutrition in children aged 2-5 years old during a food-insecure time of the year in rural villages in Guinea-Bissau. The study will use community health workers to conduct the herring distribution, making this a test that will provide valuable information on what could become a practical food aid supplementation practice. The primary study hypothesis is that distribution of canned herring as a weekly food supplement to families with young children at the beginning of the rainy season will prevent a seasonal decrease in weight-for-age Z-score (primary variable) of children with mild to moderate malnutrition at baseline.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
2 Years 至 5 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Village leaders willing to allow the study to take place in their village
  • •Village must have community health workers who are willing to do the weekly distribution of herring to enrolled families and are able to keep the necessary records documenting the distribution.
  • •Children age 2-5 currently living in a selected village
  • •Parents willing to participate in the study

排除标准

  • •There are no eligibility exclusions for this study.
  • •If a child is identified with severe malnutrition at the baseline measurement, the family will be advised to take the child for treatment rather than participate in the study.

研究组 & 干预措施

Immediate Herring

Experimental

Participants in this arm will receive the Canned Herring intervention. Families with children in this study arm will receive a weekly ration of herring throughout the 8-10 week study period (2 cans herring/day per study child), which will be distributed weekly by community health workers. Families will be instructed to feed the study child half a can of herring per day (without reducing usual home food given to the child), and to not share the remaining herring with individuals who are in the Delayed Herring study arm. When families come to collect their weekly distribution they will be asked to bring in at least 7 empty herring cans in order to receive the next ration, and will answer a question about how often the child eats the herring.

干预措施: Canned Herring (Other)

Delayed Herring (Control)

No Intervention

Families with children in this study arm will not receive any herring during the 8-10 week period when Immediate Herring families receive a weekly ration of herring. After the 8-10 week (end line) measurements, an equal amount of herring will be distributed to the family.

结局指标

主要结局

Change from Baseline in weight-for-age Z-score

时间窗: baseline, 8-10 weeks

次要结局

  • weight(baseline, 8-10 weeks)
  • height(baseline, 8-10 weeks)
  • height-for-age Z-score(baseline, 8-10 weeks)
  • mid upper arm circumference (MUAC) measurement(baseline, 8-10 weeks)

研究者

发起方
Global Food & Nutrition Inc.
申办方类型
Other
责任方
Sponsor

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